Yale University
New Haven, Connecticut, 06510, United States
Location status: Recruiting
Location contact
Veena Rao, PhD
CONTACT
NCT Number: NCT05671991
The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis.
This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
New Haven, Connecticut, 06510, United States
Location status: Recruiting
Veena Rao, PhD
CONTACT
Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks.
At 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug.
At the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
Chronic Study- Empagliflozin 10 mg for 8 weeks
Time frame: Day 0 to Day 63
Total glucose absorption in grams with empagliflozin vs. placebo
Time frame: at 4 hours
Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.
Time frame: Day 0 to Day 63
Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study
Time frame: Day 0 to Day 63
Natriuresis determined by FENa
Time frame: Day 0 to Day 63
Change in levels of IL-6 and CA-125 (in pg)
Time frame: Day 0 to Day 63
Change in peritoneal equilibration test parameters, measurement of solute transport across the peritoneal membrane (standard test carried out in PD patients to assess solute trasnport across membrane)
Time frame: Day 0 to Day 63
Change in total body water and extracellular water, using heaving water (D20)
Contact information is provided by the study sponsor or research team.
Kara Otis
CONTACT
Veena Rao, PHD
CONTACT
Yale University
Other
Acronym: EMPA-PD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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